Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Nutra Luxe MD, LLC — Predicate Candidate Screening

9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

184 daysmedian FDA review time
317 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K162371Pulsaderm ACE-All BlueNutra Luxe MD, LLC2016-12-151130
K161941Pulsaderm Acne DeviceNutra Luxe MD, LLC2016-10-19960
K160728NutraStim Hair Laser HelmetNutra Luxe MD, LLC2016-09-161840
K150826Nutra Face Lift Model PE8050Nutra Luxe MD, LLC2016-02-103170
K150370Nutra Light AdvancedNutra Luxe MD, LLC2015-07-221590
K141588NUTRA STIM HAIR LASER COMBNutra Luxe MD, LLC2015-01-082090
K141596NUTRA STIM HAIR LASER COMBNutra Luxe MD, LLC2015-01-082090
K141308NUTRA LIGHT REDNutra Luxe MD, LLC2014-08-20930
K132838NUTRA LIGHT BLUENutra Luxe MD, LLC2014-05-232550

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda